CONSULT RSV ANTIGEN TEST
Received Feb 9, 2026 · Event occurred Jan 21, 2026
Report 3009238284-2026-00003 · MDR key 24299188
Device
Generic name
Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
Manufacturer
Healgen Scientific LlcCatalog number
RSV002PBS
Lot number
2509002RST-T
Product problems
- False Negative Result
Patient
35 YR · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
A CUSTOMER REPORTED A SUSPECTED FALSE-NEGATIVE RESULT WHEN TESTING A PATIENT SAMPLE. THE CUSTOMER ALSO INDICATED THAT THE DEVICE POSITIVE CONTROL PRODUCED A NEGATIVE RESULT. THE CUSTOMER REPORTED THAT A PCR METHOD WAS USED FOR CONFIRMATORY TESTING AND YIELDED A POSITIVE RESULT. NO INFORMATION WAS PROVIDED REGARDING THE TIMING OF THE PCR TEST RELATIVE TO THE INITIAL TEST OR WHETHER THE PATIENT WAS SYMPTOMATIC.
Additional Manufacturer Narrative
THE MANUFACTURER HAS COMPLETED THE INVESTIGATION. RETAINED SAMPLES FROM THE AFFECTED LOT WERE TESTED PER ESTABLISHED PROCEDURES, AND NO ANOMALIES WERE OBSERVED. ALL DEVICES MET ACCEPTANCE CRITERIA AND PERFORMED AS INTENDED. NO PRODUCT-RELATED ISSUES WERE IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. NOTE: THIS IS THE FINAL REPORT.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROGRESS.
Description of Event or Problem
A CUSTOMER REPORTED A SUSPECTED FALSE-NEGATIVE RESULT WHEN TESTING A PATIENT SAMPLE. THE CUSTOMER ALSO INDICATED THAT THE DEVICE POSITIVE CONTROL PRODUCED A NEGATIVE RESULT. THE CUSTOMER REPORTED THAT A PCR METHOD WAS USED FOR CONFIRMATORY TESTING AND YIELDED A POSITIVE RESULT. NO INFORMATION WAS PROVIDED REGARDING THE TIMING OF THE PCR TEST RELATIVE TO THE INITIAL TEST OR WHETHER THE PATIENT WAS SYMPTOMATIC.